Cyclophotocoagulation in Glaucoma
September 8, 2023 updated by: CHU de Quebec-Universite Laval
Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial
Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce intraocular pressure in case of glaucoma. Due to concerns over complications, the main indications for this second-line treatment are refractory glaucoma medication / surgery and low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the majority of researchers and clinicians according to the published literature. Some have proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.
The aim of this study is to determine how different parameters affect the efficacy of the treatment. This is a prospective double-blinded randomized controlled trial comparing two groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000 mW for 2 seconds.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Québec, Canada, G1S 4L8
- Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients with poorly controlled high pressure glaucoma
- Cyclophotocoagulation necessary to prevent visual loss
- Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort
Exclusion Criteria:
- Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma
- Patients receiving concomitant treatment the same day as the intervention
- Patient not able to follow the prescribed post-operative treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Diode laser using conventional settings
The cyclophotocoagulation protocol is used with the conventional cyclophotocoagulation settings of 2000 mW for 2 seconds.
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1250 mW for 4 seconds.
|
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Experimental: Diode laser using modified settings
The cyclophotocoagulation protocol is used with the modified cyclophotocoagulation settings of 1250 mW for 4 seconds.
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2000 mW for 2 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraocular pressure (IOP) evolution
Time Frame: 1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op
|
The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.
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1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of complications
Time Frame: During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op
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Assessment of complications (if applicable).
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During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op
|
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Use of medication
Time Frame: 1 month, 6 months, 12 months, 18 months and 24 months post-op
|
Assessment of the topical and oral glaucoma medication at baseline and after treatment
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1 month, 6 months, 12 months, 18 months and 24 months post-op
|
|
Retreatment
Time Frame: From the initial treatment up to the last visit (24 months)
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The clinician will assess the need for retreatment based on clinical experience.
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From the initial treatment up to the last visit (24 months)
|
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Visual acuity
Time Frame: 1 month, 6 months, 12 months, 18 months and 24 months post-op
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The visual acuity will be assessed at baseline and each subsequent visit
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1 month, 6 months, 12 months, 18 months and 24 months post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Toren, Doctor, Centre de recherche du CHU de Québec : Université Laval
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
July 18, 2016
First Submitted That Met QC Criteria
August 22, 2016
First Posted (Estimated)
August 23, 2016
Study Record Updates
Last Update Posted (Actual)
September 11, 2023
Last Update Submitted That Met QC Criteria
September 8, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-2212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.